Clinical study on Kumkumadi Taila in Facial dark patches.

Phase 2/3

Completed

Conditions: Disorder of pigmentation, unspecified. Ayurveda Condition: NILIKA,

Registration Number: CTRI/2022/06/043014

Lead Sponsor: Namaskar Ayurved Private Limited

Brief Summary: It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Kumkumadi Taila in participants suffering from facial hyperpigmentation. Subjects will be asked to apply Kumkumadi Tail on face and massage for 1 minute twice daily for a period of 30 days. The primary objective of the study will be to assess change in facial hyperpigmentation. Secondary objectives of the study will be to assess changes in photographic evaluation of Facial hyperpigmentation spot, change in skin lightening effect, change in skin glow, assessment of 24 hr skin patch test, change in facial cutaneous moisturization, changes in facial wrinkles, difference in number of comedones, assessment of ability of Kumkumadi oil to absorb into the skin, oily/greasy appearance of skin after application of oil, feeling of oil on skin, global assessment for overall change, assessment of post treatment tolerability of study drug and assessment of adverse events on screening / Baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 15), visit 4 (Day 30)

Results and Conclusion:

Kumkumadi oil is safe and effective in reducingfacial hyperpigmentation (dark spots) and improving skin glow. It quickly absorbs into the skin without havingfeeling of oily/greasy, sticky and heavy. It is non-comedogenic as whiteheadsand blackheads have been significantly reduced after 30 days. Anti-ageingeffect of the Kumkumadi oil has also been observed as it effectively treatedperiorbital and perioral wrinkles.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1.Clinically diagnosed mild to moderate facial hyperpigmentation 2.Willing to comply with all requirements of the study including being photographed, at baseline and following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria

1.Subjects who have received facial treatments within the past three months, including laser, RF (radio frequency), HIFU (high-intensity focus ultrasound), or dermal filler injection.
2.Subjects with a known current history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo and rosacea 3.Subjects who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs within 21 days before entering the trial 4.Subjects on any other investigational products within 1 month prior to randomization 5.Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
6.Pregnant women 7.Known hypersensitivity to any of the ingredients of Kumkumadi Taila 8.Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in facial hyperpigmentation.	Screening / Baseline visit, visit 1 (24 hrs. post skin patch test application), visit 2 (48 hrs. post skin patch test application, visit 3 (Day 15), visit 4 (Day 30)

Secondary Outcome Measures

Name	Time	Method
1.Changes in photographic evaluation of Facial hyperpigmentation spot	2.Change in skin lightening effect

Trial Locations

Locations (1): Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital
🇮🇳
Latur, MAHARASHTRA, India
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital
🇮🇳Latur, MAHARASHTRA, India
Dr Pawar Sumol Anand
Principal investigator
8793727304
drsumolapawar@gmail.com